Efficacy of Buffered Hypertonic Saline(BHS)Nasal Irrigation in Allergic Rhinitis (AR) Children
2 other identifiers
interventional
81
1 country
1
Brief Summary
The purpose of this study is to investigate whether buffered hypertonic saline (BHS) is superior to normal saline (NSS) for improving mucociliary function and relief nasal symptoms in children with allergic rhinitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 21, 2011
CompletedFirst Posted
Study publicly available on registry
September 28, 2011
CompletedSeptember 28, 2011
September 1, 2011
4 months
September 21, 2011
September 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change from baseline in SCT at 10 minute after nasal irrigation of BHS and NSS
SCT method : subjects seated with their head upright. A rhinoprobe was used to place a small piece of saccharine on the medial aspect of the inferior turbinate approximately 1 cm, posterior to the nasal vestibule. The SCT was recorded as the subject's first perception of a sweet taste.
baseline, 10 minute after nasal irrigaiton
Secondary Outcomes (1)
The effect of BHS and NSS on clinical effectiveness
1st visit, 2nd week and 4 week follow up
Study Arms (2)
NSS irrigation salt
ACTIVE COMPARATORBHS nasal irrigaiton salt
EXPERIMENTALInterventions
nasal irrigation twice daily for 4 weeks period
nasal irrigation twice daily for 4 weeks period
Eligibility Criteria
You may qualify if:
- age 6-15 years
- diagnosed AR obtained by history, physical examination and positive skin prick test or nasal cytology
- TNSS ≥ 4 at the first visit of this study
You may not qualify if:
- Patients with a history of nasal anatomical defects
- Abnormal nasal ciliary function or an upper respiratory tract infection in the preceding 2 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Araya Satdabudha
Klong Luang, Pratumthanee, 12120, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Araya Satdhabudh, MD
Thammasat University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical professor
Study Record Dates
First Submitted
September 21, 2011
First Posted
September 28, 2011
Study Start
June 1, 2010
Primary Completion
October 1, 2010
Study Completion
December 1, 2010
Last Updated
September 28, 2011
Record last verified: 2011-09